Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80315 

Submissions’’ to the Office of Policy, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: Pras 

Pathmanathan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm 1133, Silver Spring, 

MD 20993–0002, at 301–796–3490. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CM&S can be used in a variety of 

ways in medical device applications, 

including to perform ‘‘in silico’’ (virtual) 

device testing or to influence algorithms 

within software embedded in a device. 

This guidance provides a general riskinformed framework that can be used in 

the credibility assessment of CM&S used 

in medical device regulatory 

submissions. For the purposes of this 

guidance, CM&S refers to first 

principles-based (e.g., physics-based or 

mechanistic) computational models, 

and not statistical or data-driven (e.g., 

machine learning or artificial 

intelligence-based) models. This 

guidance is intended to help improve 

the consistency and transparency of the 

review of CM&S, to increase confidence 

in the use of CM&S in regulatory 

submissions, and to facilitate improved 

interpretation of CM&S credibility 

evidence submitted in regulatory 

submissions 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of December 23, 2021 (86 FR 

72969). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including revising the 

categorization of credibility evidence 

defined in the guidance, clarifying the 

scope of the guidance, and clarifying 

how the recommendations in the 

guidance relate to the framework 

described in the FDA-recognized 

standard American Society of 

Mechanical Engineers V&V 40, 

‘‘Assessing Credibility of Computational 

Modeling through Verification and 

Validation: Application to Medical 

Devices.’’ 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number GUI01500056 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

21 CFR part; or guidance Topic OMB control 

No. 

807, subpart E ................................................................. Premarket notification ........................................................................... 0910–0120 

814, subparts A through E .............................................. Premarket approval ............................................................................... 0910–0231 

814, subpart H ................................................................. Humanitarian Device Exemption ........................................................... 0910–0332 

812 ................................................................................... Investigational Device Exemption ......................................................... 0910–0078 

860, subpart D ................................................................. De Novo classification process ............................................................. 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’.Q-Submissions and Early Payor Feedback Request Programs for 

Medical Devices.

0910–0756 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25470 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 


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80316 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 16, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific guidances and provide a 

meaningful opportunity for the public to 

consider and comment on those 

guidances. Under that process, draft 

guidances are posted on FDA’s website 

and announced periodically in the 

Federal Register. The public is 

encouraged to submit comments on 

those recommendations within 60 days 

of their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

guidances or publishes revised draft 

guidances for comment. Guidances were 

last announced in the Federal Register 

on August 22, 2023 (88 FR 57116). This 

notice announces draft product-specific 

guidances, either new or revised, that 

are posted on FDA’s website. 

II. Drug Products for Which New Draft 

Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

new draft product-specific guidances for 

industry for drug products containing 

the following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Active ingredient(s) 

Azacitidine 

Chlorhexidine gluconate 

Cimetidine 

Citalopram hydrobromide 

Deucravacitinib 

Deutetrabenazine 

Dextroamphetamine 

Edaravone 

Ferric pyrophosphate citrate (multiple reference listed drugs) 

Fingolimod lauryl sulfate 

Furosemide 

Futibatinib 

Ganaxolone 

Glycopyrrolate; Neostigmine methylsulfate 

Halobetasol propionate; Tazarotene 


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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80317 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

Active ingredient(s) 

Latanoprost 

Omidenepag isopropyl 

Risperidone 

Semaglutide 

Tapinarof 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Active ingredient(s) 

Albuterol sulfate 

Betamethasone acetate; Betamethasone sodium phosphate 

Budesonide; Formoterol fumarate dihydrate 

Emtricitabine; Tenofovir alafenamide fumarate 

Ferumoxytol 

Fluticasone propionate 

Fluticasone propionate; Salmeterol xinafoate 

Fulvestrant 

Gabapentin 

Glatiramer acetate 

Levalbuterol tartrate 

Mometasone furoate 

Naltrexone 

Primidone 

Semaglutide 

Sotorasib 

Soybean oil 

Tiotropium bromide 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that these 

draft guidances contain no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25485 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2333; FDA– 

2020–E–2334; FDA–2020–E–2336; and FDA– 

2020–E–2337] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ROZLYTREK INJECTION; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of July 8, 2022. The document 

announced the determination of the 

regulatory review period for 

ROZLYTREK INJECTION (entrectinib) 

for purposes of patent extension. The 

document was published with an 

incorrect dosage form. This notice 

corrects the dosage form of the drug 

product. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of July 8, 2022 

(87 FR 40849), the dosage form for the 

human drug product ROZLYTREK 

(entrectinib), NDA 212726, is corrected 

from ‘‘INJECTION’’ to ‘‘CAPSULES’’ for 

all instances mentioned in the notice. 

Specifically, the drug product dosage 

form is corrected from ‘‘INJECTION’’ to 

‘‘CAPSULES’’ in the following 

locations: 

1. On page 40849, the following 

corrections are made: 

• In the second column, the title of 

the document is corrected to read: 

‘‘Determination of Regulatory Review 

Period for Purposes of Patent Extension; 

ROZLYTREK CAPSULES.’’ 

• In the second column, the first 

sentence under the SUMMARY section is 

corrected to read: ‘‘The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for ROZLYTREK CAPSULES and is 

publishing this notice of that 

determination as required by law.’’ 

• In the third column, the first 

sentence under the section Instructions 

is corrected to read: ‘‘All submissions 

received must include the Docket Nos. 

FDA–2020–E–2333; FDA–2020–E–2334; 

FDA–2020–E–2336; and FDA–2020–E– 

2337 for ‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; ROZLYTREK CAPSULES.’’’ 

2. On page 40850, the following 

corrections are made: 

• In the second column, under 

section I. Background of the 

SUPPLEMENTARY INFORMATION section, the 

third paragraph introduction is 

corrected to read: ‘‘FDA has approved 

for marketing the human drug product, 

ROZLYTREK CAPSULES (entrectinib), 

NDA 212726, indicated for the 

treatment of:’’ 

• In the second and third columns, 

under section I. Background of the 

SUPPLEMENTARY INFORMATION section, the 

last paragraph is corrected to read: 

‘‘Subsequent to this approval, the 

USPTO received patent term restoration 

applications for ROZLYTREK 

CAPSULES (U.S. Patent Nos. 8,299,057; 

8,673,893; 9,029,356; and 9,085,565) 

from Genentech, Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

March 1, 2021, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of ROZLYTREK 

CAPSULES represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period.’’ 

• In the third column, under II. 

Determination of Regulatory Review 

Period, the first sentence of the 

introductory paragraph is corrected to 

read: ‘‘FDA has determined that the 

applicable regulatory review period for 

ROZLYTREK CAPSULES is 1,968 

days.’’ 

• In the third column, under II. 

Determination of Regulatory Review 

Period, the second sentence of the third 

paragraph is corrected to read: ‘‘FDA 


khammond on DSKJM1Z7X2PROD with NOTICES